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Trial registered on ANZCTR


Registration number
ACTRN12624000573550
Ethics application status
Approved
Date submitted
18/04/2024
Date registered
6/05/2024
Date last updated
6/05/2024
Date data sharing statement initially provided
6/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Inspire Beyond ICU – An audit of usual care physiotherapy in Australian and New Zealand ICU’s
Scientific title
Inspire Beyond ICU – An audit of usual care physiotherapy in Australian and New Zealand ICU’s for adults who are mechanically ventilated 5 days or longer
Secondary ID [1] 311987 0
None
Universal Trial Number (UTN)
U1111-1307-0639
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post ICU syndrome 333601 0
ventilator-associated respiratory muscle weakness 333602 0
Condition category
Condition code
Respiratory 330285 330285 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 330286 330286 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary objective is to accurately describe usual respiratory physiotherapy care in Australian and New Zealand Intensive Care Units in patients invasively mechanically ventilated >5 days.
There is no direct involvement of patients in this study, as all data is collected from the medical records and is simply auditing usual practice.
Details recorded include ventilator parameters, and any physiotherapy interventions including breathing techniques, airway clearance activities, exercise, positioning or mobilisation / rehabilitation activities.
The data will be recorded from the time of enrolment until 6 weeks or discharge from physiotherapy services, whichever happens first.
Intervention code [1] 328447 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338027 0
Frequency of usual physiotherapy treatment administered daily
Timepoint [1] 338027 0
Day 5 of mechanical ventilation, then daily until Week 6 or discharge from physiotherapy, whichever happens first
Secondary outcome [1] 434174 0
Recommended physiotherapy treatments on discharge
Timepoint [1] 434174 0
Discharge from physiotherapy (or week 6 following enrolment, whichever happens first)
Secondary outcome [2] 434424 0
Type and nature of physiotherapy intervention (including dosage where appropriate)
Timepoint [2] 434424 0
From Day 5 of mechanical ventilation, daily until discharge from physiotherapy or discharge from hospital, whichever happens first
Secondary outcome [3] 434425 0
Mobilisation level (score / 10) as recorded in the medical file
Timepoint [3] 434425 0
Day 5 of mechanical ventilation, then daily until discharge from physiotherapy or discharge from hospital, which ever happens first

Eligibility
Key inclusion criteria
Participants will be patients aged 16 years and older who are admitted to Australian and New Zealand ICUs and have been invasively mechanically ventilated >5 days
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they have been deemed inappropriate to receive physiotherapy treatment and are unlikely to survive the current hospital admission, as documented in the medical record.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used for the analysis of data collected

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
11/09/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC
Recruitment hospital [1] 26421 0
The Canberra Hospital - Garran
Recruitment hospital [2] 26422 0
Ipswich Hospital - Ipswich
Recruitment hospital [3] 26423 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 26424 0
Mackay Base Hospital - Mackay
Recruitment hospital [5] 26425 0
The Townsville Hospital - Douglas
Recruitment hospital [6] 26426 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [7] 26427 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [8] 26428 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [9] 26429 0
The Prince Charles Hospital - Chermside
Recruitment hospital [10] 26430 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [11] 26431 0
St George Hospital - Kogarah
Recruitment hospital [12] 26432 0
Wollongong Hospital - Wollongong
Recruitment hospital [13] 26433 0
John Hunter Hospital - New Lambton
Recruitment hospital [14] 26434 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [15] 26435 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [16] 26436 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [17] 26437 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [18] 26438 0
Box Hill Hospital - Box Hill
Recruitment hospital [19] 26439 0
Maroondah Hospital - Ringwood East
Recruitment hospital [20] 26440 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [21] 26441 0
Royal Perth Hospital - Perth
Recruitment hospital [22] 26442 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 42410 0
2217 - Kogarah
Recruitment postcode(s) [2] 42412 0
2305 - New Lambton
Recruitment postcode(s) [3] 42411 0
2500 - Wollongong
Recruitment postcode(s) [4] 42400 0
2605 - Garran
Recruitment postcode(s) [5] 42416 0
3050 - Parkville
Recruitment postcode(s) [6] 42415 0
3084 - Heidelberg
Recruitment postcode(s) [7] 42417 0
3128 - Box Hill
Recruitment postcode(s) [8] 42418 0
3135 - Ringwood East
Recruitment postcode(s) [9] 42419 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [10] 42413 0
3168 - Clayton
Recruitment postcode(s) [11] 42414 0
3175 - Dandenong
Recruitment postcode(s) [12] 42406 0
4020 - Redcliffe
Recruitment postcode(s) [13] 42408 0
4032 - Chermside
Recruitment postcode(s) [14] 42407 0
4101 - South Brisbane
Recruitment postcode(s) [15] 42409 0
4102 - Woolloongabba
Recruitment postcode(s) [16] 42401 0
4305 - Ipswich
Recruitment postcode(s) [17] 42405 0
4350 - Toowoomba
Recruitment postcode(s) [18] 42402 0
4575 - Birtinya
Recruitment postcode(s) [19] 42403 0
4740 - Mackay
Recruitment postcode(s) [20] 42404 0
4814 - Douglas
Recruitment postcode(s) [21] 42420 0
6000 - Perth
Recruitment postcode(s) [22] 42421 0
7250 - Launceston
Recruitment outside Australia
Country [1] 26250 0
New Zealand
State/province [1] 26250 0
Hamilton

Funding & Sponsors
Funding source category [1] 316334 0
Hospital
Name [1] 316334 0
Canberra Hospital
Country [1] 316334 0
Australia
Primary sponsor type
Hospital
Name
Canberra Hospital
Address
Country
Australia
Secondary sponsor category [1] 318515 0
University
Name [1] 318515 0
University of Canberra
Address [1] 318515 0
Country [1] 318515 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315144 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 315144 0
https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
Ethics committee country [1] 315144 0
Australia
Date submitted for ethics approval [1] 315144 0
22/03/2024
Approval date [1] 315144 0
17/04/2024
Ethics approval number [1] 315144 0

Summary
Brief summary
This study is an audit of usual care physiotherapy for intensive care patients who have experienced mechanical ventilation of 5 days or longer duration. This audit will be conducted for a two-month period following appropriate ethics and governance approvals, or until a minimum of 100 participants have been recruited, to accurately capture the usual care in several hospitals around Australia.

This audit is an essential first step prior to launching a multicentre study of a physiotherapy intervention (inspiratory muscle training) later in 2024.

Due to the negligible risk to patients, and the need to capture usual care for patients who are unconscious, this observational study has obtained a waiver of consent.

This multicentre study will be led by Canberra Hospital intensive care unit (ICU) researchers, but is overseen by a well-established group of expert researchers in ICU rehabilitation. The audit tool has been co-designed and tested by physiotherapists from various sites, with input from a consumer representative.

This study will pave the way for high-quality Canberra-led multicentre research in 2024 and beyond.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133806 0
Mrs Caitlin Ironside
Address 133806 0
Yamba Drive, Canberra Hospital, Garran ACT 2605
Country 133806 0
Australia
Phone 133806 0
+61 404 319 234
Fax 133806 0
Email 133806 0
Caitlin.Ironside@act.gov.au
Contact person for public queries
Name 133807 0
Bernie Bissett
Address 133807 0
University of Canberra, Bruce ACT 2617
Country 133807 0
Australia
Phone 133807 0
+61404319234
Fax 133807 0
Email 133807 0
Bernie.Bissett@canberra.edu.au
Contact person for scientific queries
Name 133808 0
Bernie Bissett
Address 133808 0
University of Canberra, Bruce ACT 2617
Country 133808 0
Australia
Phone 133808 0
+61 404319234
Fax 133808 0
Email 133808 0
Bernie.Bissett@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per ethical approval, no individual identifying data will be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22227Study protocol  Bernie.Bissett@canberra.edu.au 387687-(Uploaded-18-04-2024-12-21-31)-Study-related document.docx
22229Ethical approval  Bernie.Bissett@canberra.edu.au Pending



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.